International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1); Draft Guidance for Industry; Availability, 45663-45664 [2024-11313]
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Federal Register / Vol. 89, No. 101 / Thursday, May 23, 2024 / Notices
by the issuer for covered services for
each eligible enrollee in a benefit year.
HHS will compare this CSR-eligible
enrollment with the actual CSRs
provided by the issuers that participate
in the optional data submission window
to verify the issuer’s reporting of CSRs
provided. This revised collection does
not add any data elements and
continues to make summary plan level
reporting optional.
Based upon CMS’ experience in the
CSR data collection and evaluation
process, CMS is not making any
substantive changes to this information
collection. Form Number: CMS–10526
(OMB Control Number: 0938–1266);
Frequency: Annually; Affected Public:
Private Sector, Business or other forprofit and not-for-profit institutions;
Number of Respondents: 150; Number
of Responses: 150 Total Annual Hours:
2,363. (For policy questions regarding
this collection, contact Deborah Noymer
at 301–448–3755.)
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–11291 Filed 5–22–24; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2000–D–0784]
International Cooperation on
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products; Studies
to Evaluate the Safety of Residues of
Veterinary Drugs in Human Food:
Reproduction Testing (Revision 1);
Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
lotter on DSK11XQN23PROD with NOTICES1
VerDate Sep<11>2014
18:47 May 22, 2024
Jkt 262001
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
revised guidance for industry (GFI) #115
(VICH GL22) entitled ‘‘Studies to
Evaluate the Safety of Residues of
Veterinary Drugs in Human Food:
Reproduction Testing (Revision 1).’’
This draft guidance has been developed
for veterinary use by the International
Cooperation on Harmonisation of
Technical Requirements for Registration
of Veterinary Medicinal Products
(VICH). In order to establish the safety
of veterinary drug residues in human
food, a number of toxicological
SUMMARY:
evaluations are required, including the
assessment of any effects on
reproduction. The objective of this
guidance is to ensure international
harmonization of reproduction testing
that is appropriate for the evaluation of
effects on reproduction from long-term,
low-dose exposures; these effects may
be encountered from the presence of
veterinary drug residues in food.
DATES: Submit either electronic or
written comments on the draft guidance
by July 22, 2024 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
45663
2000–D–0784 for ‘‘Studies to Evaluate
the Safety of Residues of Veterinary
Drugs in Human Food: Reproduction
Testing (Revision 1).’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the guidance to the Policy and
Regulations Staff (HFV–6), Center for
Veterinary Medicine, Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
E:\FR\FM\23MYN1.SGM
23MYN1
45664
Federal Register / Vol. 89, No. 101 / Thursday, May 23, 2024 / Notices
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT: Mai
Huynh, Center for Veterinary Medicine
(HFV–142), Food and Drug
Administration, 7500 Standish Place,
Rockville, MD 20855, 240–402–0669,
Mai.Huynh@fda.hhs.gov
SUPPLEMENTARY INFORMATION:
lotter on DSK11XQN23PROD with NOTICES1
I. Background
FDA is announcing the availability of
a draft GFI #115 (VICH GL22) entitled
‘‘Studies to Evaluate the Safety of
Residues of Veterinary Drugs in Human
Food: Reproduction Testing (Revision
1).’’ This draft revised guidance has
been developed for veterinary use by the
VICH. In order to establish the safety of
veterinary drug residues in human food,
a number of toxicological evaluations
are recommended including the
assessment of any effects on
reproduction. The objective of this
guidance is to ensure international
harmonization of reproduction testing
that is appropriate for the evaluation of
effects on reproduction from long-term,
low-dose exposures; these effects may
be encountered from the presence of
veterinary drug residues in food.
FDA has participated in efforts to
enhance international harmonization
and is committed to seeking
scientifically based harmonized
technical procedures for pharmaceutical
development. One of the goals of
harmonization is to identify, and then
reduce, differences in technical
requirements for drug development
among regulatory agencies in different
countries. FDA has actively participated
in the International Council for
Harmonisation of Technical
Requirements for Pharmaceuticals for
Human Use to develop harmonized
technical requirements for the approval
of human pharmaceutical and biological
products among the European Union,
Japan, and the United States. The VICH
is a parallel initiative for veterinary
medicinal products. The goal of the
VICH is to develop harmonized
technical requirements for the approval
of veterinary medicinal products in the
European Union, Japan, and the United
States, and receives input from both
regulatory and industry representatives.
The VICH Steering Committee is
composed of member representatives
from the European Commission and
European Medicines Agency;
AnimalhealthEurope; FDA—Center for
Veterinary Medicine and U.S.
Department of Agriculture—Center for
Veterinary Biologics; the U.S. Animal
Health Institute; the Japanese Ministry
VerDate Sep<11>2014
18:47 May 22, 2024
Jkt 262001
of Agriculture, Forestry and Fisheries;
and the Japanese Veterinary Products
Association. There are 10 observers to
the VICH Steering Committee: one
representative from government and one
representative from industry of
Australia, New Zealand, Canada, South
Africa, and the United Kingdom. The
World Organisation for Animal Health
is an associate member of the VICH. The
VICH Secretariat, which coordinates the
preparation of documentation, is
provided by HealthforAnimals.
This level 1 draft guidance is being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The draft guidance, when
finalized, will represent the current
thinking of FDA on ‘‘Studies to Evaluate
the Safety of Residues of Veterinary
Drugs in Human Food: Reproduction
Testing (Revision 1).’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collections of
information in 21 CFR part 514 have
been approved under OMB control
numbers 0910–0032.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm,
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, or https://
www.regulations.gov.
Dated: May 20, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–11313 Filed 5–22–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the National Vaccine
Advisory Committee
Office of Infectious Disease and
HIV/AIDS Policy, Office of the Assistant
Secretary for Health, Office of the
AGENCY:
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
Secretary, Department of Health and
Human Services.
ACTION: Notice.
As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services (HHS) hereby gives notice that
the National Vaccine Advisory
Committee (NVAC) will hold an inperson meeting. The meeting will be
open to the public and public comment
will be heard during the meeting.
DATES: The meeting will be held June
13–14, 2024. The confirmed meeting
times and agenda will be posted on the
NVAC website at https://www.hhs.gov/
nvpo/nvac/meetings/ as soon
as they become available.
ADDRESSES: Instructions regarding
attending this meeting will be posted
online at: https://www.hhs.gov/nvpo/
nvac/meetings/ at least one
week prior to the meeting. Preregistration is required for those who
wish to attend the meeting in person or
participate in public comment. Please
register at https://www.hhs.gov/nvpo/
nvac/meetings/.
FOR FURTHER INFORMATION CONTACT: Ann
Aikin, Acting Designated Federal
Officer, Office of Infectious Disease and
HIV/AIDS Policy, U.S. Department of
Health and Human Services, Tower
Building, Room, 1101 Wootton
Parkway, Rockville, MD 20852. Email:
nvac@hhs.gov. Phone: 202–795–7697.
SUPPLEMENTARY INFORMATION: Pursuant
to section 2101 of the Public Health
Service Act (42 U.S.C. 300aa–1), the
Secretary of HHS was mandated to
establish the National Vaccine Program
to achieve optimal prevention of human
infectious diseases through
immunization and to achieve optimal
prevention against adverse reactions to
vaccines. The NVAC was established to
provide advice and make
recommendations to the Director of the
National Vaccine Program on matters
related to the Program’s responsibilities.
The Assistant Secretary for Health
serves as Director of the National
Vaccine Program.
During this meeting, NVAC will hear
presentations to support the recent
charge on innovation from Admiral
Rachel L. Levine, MD, the Assistant
Secretary for Health and Director of the
National Vaccine Program. NVAC will
also hear presentations on recent surges
in measles cases, tuberculosis and breast
cancer vaccines in development, and
mpox vaccination activities. Speakers
will also discuss progress and priorities
for the upcoming Vaccines National
Strategic Plan. Global immunization
and data modernization efforts will also
SUMMARY:
E:\FR\FM\23MYN1.SGM
23MYN1
]]>Agencies
[Federal Register Volume 89, Number 101 (Thursday, May 23, 2024)]
[Notices]
[Pages 45663-45664]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11313]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2000-D-0784]
International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products; Studies
to Evaluate the Safety of Residues of Veterinary Drugs in Human Food:
Reproduction Testing (Revision 1); Draft Guidance for Industry;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft revised guidance for industry (GFI) #115
(VICH GL22) entitled ``Studies to Evaluate the Safety of Residues of
Veterinary Drugs in Human Food: Reproduction Testing (Revision 1).''
This draft guidance has been developed for veterinary use by the
International Cooperation on Harmonisation of Technical Requirements
for Registration of Veterinary Medicinal Products (VICH). In order to
establish the safety of veterinary drug residues in human food, a
number of toxicological evaluations are required, including the
assessment of any effects on reproduction. The objective of this
guidance is to ensure international harmonization of reproduction
testing that is appropriate for the evaluation of effects on
reproduction from long-term, low-dose exposures; these effects may be
encountered from the presence of veterinary drug residues in food.
DATES: Submit either electronic or written comments on the draft
guidance by July 22, 2024 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2000-D-0784 for ``Studies to Evaluate the Safety of Residues of
Veterinary Drugs in Human Food: Reproduction Testing (Revision 1).''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the guidance to the
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine,
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests. See
[[Page 45664]]
the SUPPLEMENTARY INFORMATION section for electronic access to the
draft guidance document.
FOR FURTHER INFORMATION CONTACT: Mai Huynh, Center for Veterinary
Medicine (HFV-142), Food and Drug Administration, 7500 Standish Place,
Rockville, MD 20855, 240-402-0669, [email protected]
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft GFI #115 (VICH GL22)
entitled ``Studies to Evaluate the Safety of Residues of Veterinary
Drugs in Human Food: Reproduction Testing (Revision 1).'' This draft
revised guidance has been developed for veterinary use by the VICH. In
order to establish the safety of veterinary drug residues in human
food, a number of toxicological evaluations are recommended including
the assessment of any effects on reproduction. The objective of this
guidance is to ensure international harmonization of reproduction
testing that is appropriate for the evaluation of effects on
reproduction from long-term, low-dose exposures; these effects may be
encountered from the presence of veterinary drug residues in food.
FDA has participated in efforts to enhance international
harmonization and is committed to seeking scientifically based
harmonized technical procedures for pharmaceutical development. One of
the goals of harmonization is to identify, and then reduce, differences
in technical requirements for drug development among regulatory
agencies in different countries. FDA has actively participated in the
International Council for Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use to develop harmonized technical
requirements for the approval of human pharmaceutical and biological
products among the European Union, Japan, and the United States. The
VICH is a parallel initiative for veterinary medicinal products. The
goal of the VICH is to develop harmonized technical requirements for
the approval of veterinary medicinal products in the European Union,
Japan, and the United States, and receives input from both regulatory
and industry representatives.
The VICH Steering Committee is composed of member representatives
from the European Commission and European Medicines Agency;
AnimalhealthEurope; FDA--Center for Veterinary Medicine and U.S.
Department of Agriculture--Center for Veterinary Biologics; the U.S.
Animal Health Institute; the Japanese Ministry of Agriculture, Forestry
and Fisheries; and the Japanese Veterinary Products Association. There
are 10 observers to the VICH Steering Committee: one representative
from government and one representative from industry of Australia, New
Zealand, Canada, South Africa, and the United Kingdom. The World
Organisation for Animal Health is an associate member of the VICH. The
VICH Secretariat, which coordinates the preparation of documentation,
is provided by HealthforAnimals.
This level 1 draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent the current thinking of FDA on ``Studies
to Evaluate the Safety of Residues of Veterinary Drugs in Human Food:
Reproduction Testing (Revision 1).'' It does not establish any rights
for any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in 21 CFR part 514 have been approved under OMB control numbers 0910-
0032.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Dated: May 20, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-11313 Filed 5-22-24; 8:45 am]
BILLING CODE 4164-01-P
